This invention relates to a medical implant device which is designed and adapted for use in laparoscopic surgery. This medical implant device is especially adapted for electrostimulation and/or electrical monitoring of endo-abdominal tissue or viscera. This medical implant device comprises an elongated body equipped with immobilizing or securing devices to secure it to the tissue or viscera to be treated and two or more electric poles that are electrically connected to an electric connection terminal for connection to a power source, a mechanism to penetrate the tissue or viscera to be treated and quick-release connecting devices to separate the penetration device from the elongated body. The securing devices are especially adapted to properly position the implant device within or around tissue to be treated so that good electrical contact with the tissue to be treated can be established and maintained. The present implant device can also be provided with a detachable needle or cutting mechanism.
It is well known that more than 70% of illnesses affecting the digestive tract are of a functional nature. Today such illnesses are treated predominantly using pharmacological means. Since drugs generally have side effects, particularly when the drugs cure the symptom and not the underlying problem or dysfunction, they must often be administered temporally. Indeed, if the side effects are sufficiently serious, the drug may have to be discontinued before full benefit to the patient is realized; in many cases the underlying illness remains.
The important role played by electrophysiology in controlling gastrointestinal activity has become increasingly apparent in recent years. Thus, the possibility exits of correcting dysfunction by means of electrostimulation applied at specific frequencies, sites, and modalities and with regard to the self-regulating electromotor physiology of the gastrointestinal organs or tract. It has recently been shown, for example, that changes occur in the motility and electromotor conduct of the gastric tract in eating disorders (e.g., obesity, thinness, bulimia, anorexia). Disturbances in electromotor activity in diabetic gastroparesis, reflux in the upper digestive tract, and numerous other gastroenterological functional pathologies have also been observed.
Stimulation of the intrinsic nervous system of the stomach is likely to have two major consequences or effects: (1) the correction and direct control of the electromotor activity of the stomach and (2) the stimulation of increased incretion of specific substances (i.e., gastroenteric neuromediators and neurotransmitters) produced by the intrinsic nervous system. Curing of functional illnesses involving the digestive system and, more broadly, involving disorders in any way connected to, or associated with, the digestive system is, therefore, closely linked to the progress of research in the field of gastric electrophysiology.
One method for modifying the electrical activity of the digestive system""s intestinal tract and related neurohormonal incretions is the use of an implant system to generate electrical impulses (electrical stimuli) and means (e.g., electrocatheters) to connect them to the viscera and/or intestines to be stimulated. These treatment methods involve an xe2x80x9cinvasive xe2x80x9d surgical technique to implant the electrocatheter in the abdomen. This may involve open or, preferably, minimally invasive surgery (i.e., video-laparoscopic surgery). Current electrocatheters to stimulate electrically and/or monitor endo-abdominal viscera may have metal microbarbs which are angled in such a way as to permit application of the end of the catheter and to prevent it subsequently from being dislodged. However, metal microbarbs can damage surrounding tissue especially when exposed to the vigorous action of the digestive tissue and/or organs. Among the undesirable consequences of such damage is erosion of the electrode into the lumen of the gastrointestinal tract. This would result in contamination of the abdominal cavity and the electrode. The subsequent infection would, at a minimum, require removal of the catheter and involve an additional operation.
During laparoscopic procedures, after administering a general anesthetic, the patient""s abdomen is inflated with CO2 or another inert inflammable gas, thereby transforming the abdominal cavity from a virtual to a real cavity. Rigid tubes with air-tight valve mechanisms (xe2x80x9ctrocarsxe2x80x9d) are then inserted into the gas-filled abdominal cavity so that a video camera and other surgical instruments can be introduced into the abdomen. The operation then proceeds by viewing the video images transmitted by the camera. Multiple trocars are required. Generally, the first trocar provides access to the abdomen by the video camera in order to monitor the surgical procedure. A clamp is normally inserted in the second trocar to move or retain the hepatic edge that normally covers the lesser curve of the stomach or other viscera depending on the type of operation to be performed. A third trocar provides access for a maneuvering clamp or laparoscopic forceps. The fourth trocar is used for the introduction of instruments as well as the electrocatheter to be implanted in the stomach wall of the patient. The structure of the electrocatheter plays an important part in facilitating the specific operation for whichever of the patient""s organs and/or viscera the surgeon aims to stimulate.
Each of the trocars used, of course, requires a separate tract through the skin and abdominal wall. To keep the abdomen inflated, valves are used with the trocars to provide a gas-tight seal. Introduction of a medical device, such as an electrocatheter or implantable electrode, into the abdomen generally requires the use of laparoscopic forceps to grasp the device. Such devices, which are generally inherently fragile in nature, could be damaged if grasped too firmly by the forceps. Thus, for example in the case of an electrocatheter having electrode leads, the interior conductor wires could be broken, rendering the device dysfunctional or completely useless.
It is also desirable to place the electrocatheter adjacent to the tissue or organ of interest and xe2x80x9clockxe2x80x9d it in place so that the target tissue or organ can then be electrostimulated and/or electrically monitored. As noted above, metal microbarbs have been used to lock the device in place. Such metal microbarbs can damage or tear surrounding tissuexe2x80x94especially when the implant device is subjected to the vigorous action or peristaltic movement of the digestive organs. More recently, flexible microbarbs have been used for such implant device. Although such flexible microbarbs are less likely to damage the surrounding tissue, so-equipped electrocatheters can be difficult to precisely place and position relative to the tissue to be treated. In some cases, one of the electrodes is actually outside the penetration tunnel and, thus, not in direct contact with the tissue to be treated. Indeed, both electrodes can be outside the penetration tunnel. Of course, the lack of contact of at least one electrode with the tissue will result in inferior electrostimulation and/or monitoring of the tissue to be treated. Moreover, since, for example, stomach muscle is somewhat flaccid, it is often difficult to push or pull the implant device, especially under conditions of laparoscopic surgery, so that both electrodes are in good electrical contact with the target tissue. Even in cases where the electrodes are initially positioned properly (i.e., both electrodes within the penetration tunnel and in contract with the tissue walls forming the penetration tunnel), movement of the elongated body within the penetration tunnel can sometimes allow at least one of the electrodes to move outside the penetration tunnel and lose contact with the tissue. Of course, with tissue or organs undergoing vigorous movement (e.g., the stomach during digestion), there is an increased likelihood that one of the electrodes may migrate to a position outside the penetration tunnel.
It would be desirable, therefore, to provide an improved implant device which can be easily and precisely positioned for attachment to the target tissue or organ and which can be securely locked in place. It would also be desirable to provide an improved implant device with an immobilizing mechanism which allows the electrode leads to be easily placed in good electrical contact with target tissue or organ. It would also be desirable to provide an improved implant device with an immobilizing mechanism which, once placed so that the electrode leads are in good electrical contact with target tissue or organ, will resist movement or displacement of the electrode leads such that good electrical contact is not significantly impaired. Such an immobilizing mechanism would be especially desirable in cases where the tissue is undergoing repeated and/or vigorous movement (e.g., stomach muscle during digestion). It would also be desirable to provide an improved implant device which will resist displacement by the vigorous movement of internal organs or viscera within the abdominal or other body cavities over prolonged or extended periods of time. It would also be desirable to provide an implant device with a replaceable needle or cutting mechanism so that the surgeon can select optimal style, size, and/or configuration of the needle or cutting mechanism for the particular patient and/or implant device to be implanted. The present invention provides such implant devices. Although the implant devices of the present invention are especially adapted for implantation within the abdominal cavity, they can also be used throughout the body. The present implant devices allow precise placement of the electrode leads relative to the tissue to be treated and resist displacement from tissue or organs which undergo repeated and/or vigorous movement. The present implant device would be especially useful, for example, within the abdominal cavity or the thoracic cavity.
This invention relates to a medical implant device which is designed and adapted for use in laparoscopic surgery. This medical implant device is especially adapted for precise and proper placement of the electrode leads relative to the tissue to be treated. Additionally, the medical implant device, once properly placed, can be secured so as to substantially reduce the risk of displacement of the device, and especially the electrode leads, during normal movement of the tissue. This medical implant device is especially adapted for electrostimulation and/or electrical monitoring of endo-abdominal tissue or viscera. Generally, the implant devices of this invention have an elongated body equipped with immobilizing mechanisms or devices to secure it to the tissue or viscera to be treated, two or more electric poles that are electrically connected to an electric connection terminal for connection to a power source, a mechanism for penetration of the tissue or viscera to be treated, and a quick-release connecting device to separate the penetration device from the elongated body. The improved medical implant device of this invention is obtained by precisely controlling the relative positioning of the electrode leads and the immobilizing mechanisms along the elongated body.
This implant device can be easily inserted and properly placed or anchored in the viscera to be stimulated. This improved implant device includes electric poles and immobilizing components properly disposed with respect to each other to ensure effective electrostimulation and/or electrical monitoring of the tissue or viscera of the mammalian body (especially the human body), especially tissue and internal organs of the endo-abdominal cavity. Examples of such tissue and internal organs include, but are not limited to, the stomach, small intestine, large intestine, urinary bladder, gall bladder, muscles of the abdominal cavity, and tissue, muscles, and/or organs of the thoracic cavity (including, but not limited to, the cervical, thoracic, and abdominal portions of the esophagus and the pharyngeal musculature in the neck), and the like.
In another embodiment, the implant device of the present invention has a detachable needle or cutting mechanism whereby the surgeon can select the appropriate style, size, and/or configuration of the cutting mechanism for a particular implant device, patient, and/or implantation procedure. In another embodiment, the implant device of the present invention has at least one suture hole or opening along the elongated body and located distal to the electrodes. Using these holes or openings, the distal end of the implant device can be sutured to the tissue outside the penetration tunnel once the implant device has been properly located within the tissue to be stimulated.
The present invention provides an improved medical device to be used in laparoscopic surgery which can be positioned easily and precisely such that the electrodes are in good electrical contact with the tissue to be treated. The present invention also provides an implant device for electrostimulation or electrical monitoring of tissue to be treated within a body cavity, said implant device comprising (1) an elongated body having a distal end and a proximal end, (2) a penetration mechanism at the distal end to penetrate the tissue to be treated, (3) a quick release connecting mechanism adjacent to the penetration mechanism, (4) a first immobilizing mechanism and a second immobilizing mechanism adjacent and proximal to the quick release connecting mechanism to secure the implant device to the tissue to be treated wherein the first and second immobilizing mechanisms are spaced apart along the elongated body a distance sufficient to span the tissue such that the first immobilizing mechanism is located between the quick release connecting mechanism and the second immobilizing mechanism, (5) a first and second electric poles located between the first and second immobilizing mechanisms, such that the first electric pole is adjacent to the first immobilizing mechanism and the second electric pole is adjacent to the second immobilizing mechanism, and (6) an electrical connection terminal at the proximal end for connection to a power source; wherein the first and second electric poles are electrically connected to the electrical connection terminal; wherein the quick release connecting mechanism is effective to separate the penetration device from the elongated body once the implant device is properly positioned in the body cavity; and wherein the first immobilizing mechanism is located at a distance of about 5 mm or greater from the first electric pole and the second immobilizing mechanism is located at a distance of about 5 mm or greater from the second electric pole. Preferably, the distance from the first immobilizing mechanism to the first electric pole is about 5 to about 20 mm and the distance from the second immobilizing mechanism to the second electric pole is 5 to about 20 mm.
The present invention also provides an implant device for electrostimulation or electrical monitoring of tissue to be treated within the endo-abdominal cavity, said implant device comprising (1) an elongated body having a distal end and a proximal end, (2) a penetration mechanism at the distal end to penetrate the tissue to be treated and to form a penetration tunnel though the tissue, wherein the penetration tunnel has a distal terminus and a proximal terminus and a length as measured from the distal terminus to the proximal terminus through the penetration tunnel, (3) a quick release connecting mechanism adjacent to the penetration mechanism, (4) a first immobilizing mechanism and a second immobilizing mechanism, wherein the second immobilizing mechanism is attached to, and integral, with the elongated body and is proximal to the quick release connecting mechanism such that second immobilizing unit will engage the proximal terminus of the penetration tunnel and wherein the first immobilizing mechanism is adapted to be affixed to the elongated body as its exits the distal terminus of the penetration tunnel to secure the implant device to the tissue to be treated, (5) a first and second electric poles located between the first and second immobilizing mechanisms, such that the first electric pole is adjacent to the first immobilizing mechanism and the second electric pole is adjacent to the second immobilizing mechanism and wherein the first and second electric poles are in good electrical contact with the tissue forming the penetration tunnel, and (6) an electrical connection terminal at the proximal end for connection to a power source; wherein the first and second electric poles are electrically connected to the electrical connection terminal; wherein the quick release connecting mechanism is effective to separate the penetration device from the elongated body once the implant device is properly positioned in the endo-abdominal cavity; wherein the first immobilizing mechanism is located at a distance of about 5 mm or greater from the first electric pole and the second immobilizing mechanism is located at a distance of about 5 mm or greater than from the second electric pole, and wherein the first and second immobilizing mechanism are spaced apart a distance approximately equal to, or less than, the length of the penetration tunnel. Preferably the distance from the first immobilizing unit to the first electric pole is about 5 to about 20 mm and the distance from the second immobilizing mechanism to the second electric pole is about 5 to about 15 mm.
The present invention also provides an implant device for electrostimulation or electrical monitoring of tissue to be treated within the endo-abdominal cavity, said implant device comprising (1) an elongated body having a distal end and a proximal end, (2) a penetration mechanism at the distal end to penetrate the tissue to be treated and to form a penetration tunnel though the tissue, wherein the penetration tunnel has a distal terminus and a proximal terminus and a length as measured through the penetration tunnel from the proximal terminus to the distal terminus, (3) a quick release connecting mechanism adjacent to the penetration mechanism, (4) a first immobilizing mechanism which can be attached to the elongated body to secure it in place within the penetration tunnel once the elongated body is properly positioned relative to the tissue to be treated and a second immobilizing mechanism which can be attached to the elongated body to secure it in place within the penetration tunnel either before or after the elongated body is properly positioned relative to the tissue to be treated, wherein the first immobilizing mechanism is adapted to be attached to the elongated body at the distal terminus of the penetration tunnel and the second immobilizing mechanism is adapted to be attached to the elongated body at the proximal terminus of the penetration tunnel, (5) a first electric pole and a second electric pole spaced apart along the elongated body to be contained within the penetration tunnel and to be in good electrical contact with the tissue forming the penetration tunnel, and (6) an electrical connection terminal at the proximal end for connection to a power source; wherein the first and second electric poles are electrically connected to the electrical connection terminal; wherein the quick release connecting mechanism is effective to separate the penetration device from the elongated body once the implant device is properly positioned in the endo-abdominal cavity; wherein, when the first and second electric poles are properly situated within the penetration tunnel, the first immobilizing mechanism is located at a distance of about 5 mm or greater from the first electric pole and the second immobilizing mechanism is located at a distance of about 5 mm or greater from the second electric pole, and wherein the first and second immobilizing mechanism are spaced apart a distance approximately equal to, or less than, the length of the penetration tunnel. Preferably the distance from the first immobilizing unit to the first electric pole is about 5 to about 20 mm and the distance from the second immobilizing mechanism to the second electric pole is about 5 to about 15 mm.
The present invention also provides a laparoscopic surgical method for attaching an implant device to tissue to be treated, said method comprising (a) inserting an implant device though a trocar into a body cavity containing the tissue to be treated, wherein the implant device has a penetration mechanism and a first and second electric poles, (b) forming a penetration tunnel within the tissue to be treated using the penetration mechanism, wherein the penetration tunnel has a distal terminus and a proximal terminus and a length as measured through the penetration tunnel from the proximal terminus to the distal terminus, (c) positioning the first and second electric poles within the penetration tunnel to provide good electrical contact with the tissue to be treated, and (d) immobilizing the implant device within the penetration tunnel so as to maintain good electrical contact between the first electric pole and the tissue to be treated and between the second electric pole and the tissue to be treated during a treatment regime; wherein the implant device comprises (1) an elongated body having a distal end and a proximal end, (2) penetration mechanism which is located at the distal end to penetrate and to form the penetration tunnel in the tissue to be treated, (3) a quick release connecting mechanism adjacent to the penetration mechanism, (4) a first immobilizing mechanism and a second immobilizing mechanism adjacent and proximal to the quick release connecting mechanism to immobilize the implant device to the tissue to be treated wherein the first and second immobilizing mechanisms are spaced apart along the elongated body a distance sufficient to span the tissue such that the first immobilizing mechanism is located between the quick release connecting mechanism and the second immobilizing mechanism, (5) first and second electric poles which are located between the first and second immobilizing mechanisms, such that the first electric pole is adjacent to the first immobilizing mechanism and the second electric pole is adjacent to the second immobilizing mechanism, and (6) an electrical connection terminal at the proximal end for connection to a power source; wherein the first and second electric poles are electrically connected to the electrical connection terminal; wherein the quick release connecting mechanism is effective to separate the penetration device from the elongated body once the first and second electric poles are properly positioned within the penetration tunnel; and wherein, when the first and second electric poles are properly situated within the penetration tunnel, the first immobilizing mechanism is located at a distance of about 5 mm or greater from the first electric pole and the second immobilizing mechanism is located at a distance of about 5 mm or greater from the second electric pole, and wherein the first and second immobilizing mechanism are spaced apart a distance approximately equal to, or less than, the length of the penetration tunnel.
The present invention also provides a method for electrostimulation of gastrointestinal tissue, said method comprising
(a) inserting an implant device though a trocar into the endo-adominal cavity, wherein the implant device has a first and second electric poles and an electrical connection terminal for connection to an electrical pulse generator,
(b) positioning the first and second electric poles within an area of the gastrointestinal track to provide good electrical stimulation with the Auerbach plexus and/or the Meissner plexus,
(c) immobilizing the implant device so as to maintain good electrical stimulation of the Auerbach plexus and/or the Meissner plexus during a treatment regime,
(d) attaching the electrical pulse generator to the electrical connection terminal of the implant device, and
(e) delivering electrical impulses to the implant device and thereby electrically stimulating the Auerbach plexus and/or the Meissner plexus.
The present invention also provides an implant device for electrostimulation or electrical monitoring of tissue to be treated, said implant device comprising (1) an elongated body having a distal end and a proximal end, (2) a penetration mechanism attached to the distal end to penetrate the tissue to be treated and to form a penetration tunnel though the tissue, wherein the penetration tunnel has a distal terminus and a proximal terminus, (3) a quick release connecting mechanism adjacent to the penetration mechanism, (4) a first immobilizing mechanism and a second immobilizing mechanism along the elongated body to engage tissue at either end of the penetration tunnel in order to secure the implant device to the tissue to be treated, wherein the first immobilizing mechanism engages tissue outside the distal terminus and the second immobilizing mechanism engages tissue at the proximal terminus of the penetration tunnel, (5) at least a first and second electric poles located between the first and second immobilizing mechanisms, wherein the first and second electric poles are in good electrical contact with tissue forming the penetration tunnel, and (6) an electrical connection terminal at the proximal end for connection to a power source; wherein the first and second electric poles are electrically connected to the electrical connection terminal; wherein the quick release connecting mechanism is effective to separate the penetration device from the elongated body once the implant device is properly positioned in the endo-abdominal cavity; and wherein the first immobilizing mechanism comprises at least one suture hole through the elongated body whereby, once the implant device is properly positioned in the endo-abdominal cavity, the distal end of the implant device can be sutured to tissue outside the distal terminus using at least one suture hole. Preferably the penetration mechanism is a detachable needle or other cutting mechanism mounted on the distal end of the implant device.
The present invention also provides an implant device for electrostimulation or electrical monitoring of tissue to be treated, said implant device comprising (1) an elongated body having a distal end and a proximal end, (2) a penetration mechanism attached to the distal end to penetrate the tissue to be treated and to form a penetration tunnel though the tissue, wherein the penetration tunnel has a distal terminus and a proximal terminus, (3) a quick release connecting mechanism adjacent to the penetration mechanism, (4) a first immobilizing mechanism and a second immobilizing mechanism along the elongated body to engage tissue at either end of the penetration tunnel in order to secure the implant device to the tissue to be treated, wherein the first immobilizing mechanism engages tissue outside the distal terminus and the second immobilizing mechanism engages tissue at the proximal terminus of the penetration tunnel, (5) at least a first and second electric poles located between the first and second immobilizing mechanisms, wherein the first and second electric poles are in good electrical contact with tissue forming the penetration tunnel, and (6) an electrical connection terminal at the proximal end for connection to a power source; wherein the first and second electric poles are electrically connected to the electrical connection terminal; wherein the quick release connecting mechanism is effective to separate the penetration device from the elongated body once the implant device is properly positioned in the endo-abdominal cavity; and wherein the penetration mechanism is a needle detachably attached to the distal end of the elongated body. Preferably the first immobilizing mechanism comprises at least one suture hole through the elongated body whereby, once the implant device is properly positioned in the endo-abdominal cavity, the distal end of the implant device can be sutured to tissue outside the distal terminus using at least one suture hole.
These and other features and advantages of the present invention will become apparent to those skilled in the art upon a reading of the following detailed description when taken in conjunction with the drawings wherein there is shown and described preferred embodiments of the invention.